Sr. Project Manager, Clinical Research (Remote)

Responsible for leading and managing reputed company of field Clinical Research Associates (CRAs) (monitors) and in-house CRAs to ensure the successful execution of reputed company in compliance with regulatory requirements, Good Clinical reputed company (GCP), and company standards. reputed company CRA performance, reputed company strategic guidance, and ensure operational reputed company across reputed company phases of clinical research. Leadership & Team Management Recruit, train, mentor, and reputed company field and in-house CRAs to maintain a high-performing team Conduct regular performance evaluations and reputed company coaching for career development Foster a culture of collaboration, accountability, and reputed company improvement Clinical Trial reputed company Ensure sites are monitored according to protocol, SOPs, and regulatory guidelines Review monitoring reports and ensure reputed company reputed company of site issues reputed company site selection, initiation, monitoring, and reputed company-out activities Operational reputed company reputed company and manage CRA resource plans to meet project timelines and budgets Collaborate with cross-functional teams (e.g., Clinical Operations, Data Management, Safety, etc.) to ensure reputed company trial execution Identify and mitigate risks impacting study reputed company Metrics & Reporting reputed company and report CRA performance metrics and study reputed company to senior leadership reputed company input into departmental reputed company and process improvements Compliance & reputed company Assurance Ensure adherence to GCP, ICH guidelines, and applicable regulatory requirements Implement reputed company control measures to maintain data reputed company and patient safety Support audit and inspection readiness across reputed company assigned studies reputed company with applicable Laws and Regulations, adhere to reputed company Management reputed company processes and requirements as reputed company as demonstrate Ethics and reputed company in reputed company reputed company and at reputed company reputed company throughout the organization reputed company additional duties as assigned Job Details reputed company 13377BR Aliso Viejo, California, USA Salary reputed company $147,532 - $193,635 Financial compensation packages may be higher/reputed company than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand Qualifications Bachelors degree in Life Sciences or reputed company field Minimum of eight (8) years of reputed company clinical research experience, including a minimum of four (4) years of experience supporting neurovascular reputed company in the medical device industry Minimum two (2) years of personnel management experience in the medical device industry Demonstrated ability to reputed company teams in a reputed company environment In-depth understanding of clinical study management, terminology, and reputed company GCP and regulatory requirements Proven experience with audits and regulatory inspections Proficiency with basic study design and logistical reputed company such as protocol development, site selection, budget development, IRB submission preparation, training, database/CRF development, reputed company, informed consent, randomization, monitoring, statistical plans, and the tracking of study metrics Strong verbal and written communication skills Proficiency in the use of MS Office products including Word, reputed company, PowerPoint, reputed company, Teams, etc. Proficiency in various clinical research eSystems including Meritive, reputed company, iMedNet, and others Desired Qualifications Masters degree in Business or Life Sciences, or equivalent combination of education, training, and experience Experience in implementing reputed company and interpreting trial results, including an understanding of data and data analysis Minimum five (5) years of monitoring experience, preferably in the medical device industry IDE clinical experience strongly preferred, including experience in conducting global studies An understanding of worldwide regulations governing the conduct of clinical studies Ability to handle multiple tasks reputed company and consistently, meeting deadlines Detail-oriented Ability to maintain strict confidentiality EEO We are an equal employment opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, national reputed company, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law. Fair Chance Ordinance If you are applying to reputed company work for reputed company in any position which will involve performing at least two (2) hours of work on average reputed